Study To Assess The Effect Of PF-04531083 On Heat Pain In Healthy Volunteers With Ultraviolet Light Sensitized Skin

A Randomized, Double-Blind, Double-Dummy, Placebo And Active Comparator Controlled 4-Period Cross-Over Study To Assess The Effect Of PF-04531083 On Heat Pain In The UVB-Induced Pain Model In Healthy Volunteers

PF-04531083 has been shown to reduce the amount of heat pain experienced by rats with skin that has been sensitized to heat by ultraviolet light. This study is designed to see if this is also true in man.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-04531083 100mg; Drug: PF-04531083 2000mg; Drug: Placebo suspension; Drug: Placebo tablet; Drug: Oxycodone 20mg

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, B-1070
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy volunteers.
• Body mass index between 17.5 - 30.5 kg/m2 and body weight greater than 50 kg.

Exclusion Criteria:

• Subjects that have any condition possibly affecting drug absorption (eg, gastrectomy).
• Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
• Subjects with inadequate cardiac function (ECG demonstrating prolonged QTc interval at screening).
• Subjects with inadequate or excessive sensitivity to UVB light.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Randomized cross-over sequence; Randomized unbalanced sequence of incomplete block design with replicates within sequence	Drug: PF-04531083 100mg; Oral PF-04531083 100mg suspension single dose; Drug: PF-04531083 2000mg; Oral PF-04531083 2000mg suspension single dose; Drug: Placebo suspension; Oral Placebo suspension (matched to PF-04531083 suspension); Drug: Placebo tablet; Oral Placebo tablet (matched to Oxycodone); Drug: Oxycodone 20mg; Oral Oxycodone 20mg (Oxycontin) controlled release formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To assess the effect of PF-04531083 by using the Heat Pain Tolerance Threshold in the area of UVB-induced erythema (HPTTu) endpoint at 2, 4, 6 and 24 hours.	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Heat Pain Perception Threshold in the area of UVB-induced erythema (HPPTu) at 2, 4, 6 and 24 hours.	24 hours
Heat Pain Perception Threshold on control skin (HPPTc) at 2, 4, 6 and 24 hours	24 hours
Summary of plasma concentrations of PF-04531083	24 hours
Exploratory colorimetric data collected from baseline and MED test exposure areas	24 hours

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: May 20, 2010
• First Submitted That Met QC Criteria: May 20, 2010
• First Posted (Estimate): May 21, 2010

Study Record Updates

• Last Update Posted (Estimate): September 23, 2010
• Last Update Submitted That Met QC Criteria: September 22, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Healthy Volunteers; cross-over; randomized; placebo and active controlled; heat pain; UVB-Induced pain model
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Oxycodone
• Other Study ID Numbers: B1351003